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Report: BD’s Bard unit to pay $4.8M in hernia mesh lawsuit

The C.R. Bard unit of BD (NYSE:BDX) was ordered to pay $4.8 million in a lawsuit related to its hernia mesh, Reuters reports.

The news agency said the company must pay nearly $5 million in a lawsuit brought by a Hawaii man who said he suffered serious complications from the implanted hernia repair mesh. BD will appeal the decision, a spokesperson told Reuters.

Paul Trevino and his wife, Earlynn, alleged in a 2018 lawsuit that the Ventralex hernia repair mesh from BD’s Bard business dug into his tissue, causing pain and inflammation while eventually leading to required corrective surgery, according to the report.

A Rhode Island jury handed down the verdict following a month-long trial, Reuters said. BD faces more than 30,000 lawsuits of a similar kind related to hernia mesh devices.

Mesh devices have been the subject of legal challenges over the years, proving to potentially be one of medtech’s greatest modern failures. Pelvic mesh prod…

Philips Respironics has a new serious recall for certain ventilators

Philips (NYSE:PHG) has a new FDA Class I recall for its ventilators, adding to recall issues that have plagued the company for a year.

The FDA issued a notice alerting patients, caregivers and providers that certain Philips Respironics bi-level positive airway pressure (BiPAP or BPAP) machines may contain a plastic contaminated with a non-compatible material. If such plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). It may also cause the machine to fail and stop working suddenly during use.

FDA said the potential risks of inhaling VOCs include headaches, dizziness, irritation in the eyes, nose, respiratory tract and skin, hypersensitivity reactions, nausea or vomiting and toxic and cancer-causing effects. If the plastic causes the machine to fail and stop working suddenly, it may lead to serious injury or death.

At this stage, the FDA is not aware of any reports of serious injury or deat…

FDA approves ‘first-in-market’ autoinjector for treating prolonged seizures

[Image from Rafa]Rafa Laboratories announced today that it received FDA approval for its 10mg Midazolam autoinjector for treating status epilepticus (prolonged seizures).

Jerusalem-based Rafa developed the autoinjector through cooperation with the U.S. Department of Defense’s (D0D) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).

Rafa’s Midazolam 10mg autoinjector received FDA indication for the treatment of status epilepticus, or prolonged seizures, in adults. This means the new autoinjector can be used to treat seizures resulting from nerve agent exposure. JPEO-CBRND determined that the autoinjector improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA), the diazepam autoinjector.

Get the full story at our sister site, Drug Delivery Business News.

Second Sight Medical merges with Nano Precision Medical, rebrands as Vivani Medical

Second Sight Medical (Nasdaq:EYES) announced today that it completed its merger with Nano Precision Medical and rebranded.

In February, the two companies entered into a definitive agreement under which Nano Precision Medical (NPM) will merge with a wholly-owned subsidiary of Second Sight in an all-stock transaction, with NPM the surviving company under Second Sight’s ownership.

Get the full story at our sister site, Drug Delivery Business News.

Medtronic completes Affera acquisition

Medtronic (NYSE:MDT) announced today that it completed its acquisition of cardiac mapping and ablation technology developer Affera.

Newton, Massachusetts-based Affera designs and manufactures cardiac mapping and navigation systems, as well as catheter-based cardiac ablation technologies, including a differentiated, focal pulsed-field ablation platform for treating cardiac arrhythmias like AFib.

In January, Medtronic announced an agreement to acquire Affera, with CEO Geoff Martha labeling the deal as a nearly $1 billion transaction at the J.P. Morgan Healthcare Conference, adding that it includes a $250 million contingent consideration.

The company had been a strategic investor in Affera through its minority investment portfolio. Prior to the acquisition, Medtronic held a 3% stake in the company.

According to a news release, the acquisition expands Medtronic’s cardiac ablation portfolio. The portfolio will now include its first-ever cardiac m…

Medtronic implantable cardioverter defibrilator meets trial endpoints

Medtronic (NYSE:MDT) announced that its investigational EV ICD (implantable cardioverter defibrilator) system met trial endpoints.

The medtech giant designed its EV ICD system to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA). Medtronic’s device aims to avoid certain risks of traditional, transvenous ICDs as its lead (thin wire) is placed outside the heart and veins, under the breastbone (sternum) using a minimally invasive approach.

Placement in such a location aims to help avoid long-term complications that may be associated with leads in the heart and veins, including vessel occlusion and risks for blood infections.

Results from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study were presented as late-breaking science at the European Society of Cardiology (ESC) Congress 2022 in Barcelona and simultaneously published in The New England Journal of Medicine, according to a news release…

CereVasc completes first eShunt procedure in U.S.

CereVasc announced today that it completed the first procedure with the eShunt device in the U.S. as part of a pilot study.

Boston-based CereVasc’s first eShunt procedure was completed as part of a U.S. pilot study of the system in normal pressure hydrocephalus (NPH) being conducted under FDA investigational device exemption (IDE). Approval for the trial came from the FDA in February.

Dr. Charles Matouk, associate professor of neurosurgery, vice chair of clinical affairs for neurosurgery and chief of neurovascular surgery at Yale Medicine, treated the patient.

“We are pleased to participate in this study of the eShunt System, a promising device with the potential to transform the care of patients with NPH using a minimally invasive approach as opposed to open surgery,” Matouk said in a news release.

CereVasc Chair and CEO Dan Levangie added: “This study, which will evaluate the safety and efficacy of the eShunt System, repr…

Intera Oncology has a serious infusion pump recall

[Image from Intera Oncology’s webiste]The FDA issued a notice today declaring that the recall of an infusion pump from Intera Oncology is Class I, the most serious kind.

Intera recalled the Intera 3000 hepatic artery infusion pump after receiving reports from clinicians that the pumps were delivering medications (flow rate) faster than expected. If the pump delivers infusions at faster than expected flow rates, the patient may receive too much medication at one time, resulting in life-threatening hematologic (myelosuppression) toxicity, neurotoxicity or death.

Get the full story at our sister site, Drug Delivery Business News.

Galaxy Medical wins CE mark for pulsed electric field system for treating AFib

Galaxy Medical announced today that it received CE mark approval in Europe for its Centauri pulsed electric field (PEF) system.

San Carlos, California-based Galaxy Medical designed its Centauri system to target arrhythmias by delivering quick bursts of high-voltage, high-frequency energy for the treatment of paroxysmal AFib.

The company said in a news release that Centauri is the first commercially available system to enable PEF ablation with focal catheters which are used in the majority of cardiac ablation procedures worldwide.

“From the beginning, we designed Centauri to be the workhorse PEF system for all electrophysiology labs, enabling physicians to maintain use of their favored mapping systems and catheters,” Galaxy Medical CEO Dr. Jonathan Waldstreicher said in the release. “Our goal is to provide a safer and more effective alternative to thermal ablation for all practitioners of cardiac arrhythmia ablation, and the CE mark allo…

FDA clears Neuronetics’ motor threshold detection tech

Neuronetics (Nasdaq:STIM) announced today that it received FDA 510(k) clearance for its D-Tect MT accessory for the NeuroStar platform.

Malvern, Pennsylvania-based Neuronetics designed its D-Tect accessory to simplify the motor threshold (MT) determination for physicians.

According to a news release, the now FDA-cleared technology gives clinicians a way to determine MT by visually reporting the magnitude of finger movements during MT mapping for the treatment of major depressive disorder (MDD).

D-Tect also allows the MT determination to be performed by just one person, Neuronetics said. The company will make D-Tect available through a limited commercial launch initially, with a national rollout slated for mid-September. Practices will be trained on the product at NeuroStar University, which recently opened in Charlotte, North Carolina.

“The FDA clearance for the D-Tect MT Accessory is the next chapter in our plan to simplify and accelerate the MT …

Study says Abbott’s HeartMate3 heart pump extends survival by 5 years

The HeartMate 3 LVAD. [Image courtesy of LVAD]Abbott (NYSE:ABT) announced today that data demonstrates extended survival for advanced heart failure patients using HeartMate 3.

Data from the Momentum 3 trial — the world’s largest randomized clinical trial to assess long-term outcomes in people receiving a left ventricular assist device (also known as an LVAD or heart pump) to treat advanced heart failure — were presented during a late-breaking session at the 2022 European Society of Cardiology Congress in Barcelona, Spain.

The study demonstrated that HeartMate 3 extends the survival of advanced heart failure patients by at least five years, highlighting it as a life-saving option for people with later-stage disease.

According to a news release, Momentum 3 evaluated more than 1,000 patients and, for the first time in a clinical trial setting, found that people with advanced heart failure who received the HeartMate 3 heart pump lived beyond five years. T…

Össur acquires finger prosthetics company Naked Prosthetics

Össur (NSDQ:OSSR) announced today that it acquired Naked Prosthetics and its offerings for finger and partial hand amputees.

Hämeenlinna, Finland-based Össur’s acquisition of Naked Prosthetics, a developer of mechanical devices individually designed to mimic the natural motion of the finger, went into effect on Aug. 26, 2022.

The company said in a news release that its acquisition addresses a critical need for patients with finger and partial hand loss, adding to the Össur product portfolio while strengthening its limb product offerings around the globe. It also allows the company to address a broader group of amputees.

“Naked Prosthetics has developed functional and high-quality finger prostheses that complement our product portfolio and add an important range to our upper limb product offering,” said Össur President and CEO Sveinn Sölvason. “The acquisition strengthens our global market position, and we are pleased to welcome th…